1677 Improv courses in Cardiff delivered Live Online

All organizations have policies and procedures that guide how decisions are made and how the work is done in that organization. Professionally written policies and procedures increase organizational accountability and transparency and are fundamental to quality/standards assurance and quality improvement.

Course Information Our comprehensive course is used as a gateway to those stepping into the world of auditing clinical studies. Tailored for those already acquainted with Good Clinical Practice (GCP) and those transitioning from other audit disciplines, this programme stands as a pivotal guide. Pre-existing knowledge of GCP will significantly enhance your learning experience in auditing against these guidelines. How is this course run? Engage in immersive workshops providing hands-on practice with auditing techniques in a GCP context. Our seasoned tutors, boasting extensive audit experience, intertwine theory with practical insights drawn from their own professional journeys. What will I learn? A comprehensive understanding of the historical backdrop and objectives driving Good Clinical Practice, incorporating the latest industry developments Solid grounding in quality assurance activities aligned with regulatory standards Insight into potential pitfalls within clinical trials and the pivotal role of auditors in addressing these issues Clarity on the roles and responsibilities inherent to clinical trials auditing Exposure to a diverse range of audit techniques complemented by illustrative examples and supportive documents A nuanced understanding of regulatory inspectors' activities Expanded professional networks to propel your auditing career forward. Benefits include: A clear understanding of the role of the auditor under Good Clinical Practice improved audits Improved Good Clinical Practice compliance for your clinical trials. This course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Examine particular aspects of Good Clinical Practice. Tutors Tutors will be comprised of (click the photos for biographies): Rosemarie Corrigan EVP Global Quality, Worldwide Clinical Trials Cathy Dove Director and Owner, Dove Quality Solutions Julie Kelly Associate Director, Clinical Quality Assurance, Corcept Therapeutics Susana Tavares Director of Research Quality Assurance, - Programme Please note timings may be subject to alteration. Day 1 12:30 Registration 13:00 Welcome and Objectives for the first day of the course 13:30 Laying the Foundations Introduction to the clinical development process, the concepts of quality assurance, quality control and audit. 14:30 Break 15:00 Patient Protection Requirements for informed consent and ethics committee. Access to source documentation. Including a patient protection exercise. 16:05 Workshop 1 - Case Study on Informed Consent 16:45 End of Day Questions and Answers 17:00 Close of Day Day 2 08:50 Questions and Answers from Day 1 09:00 Effective Site Audits The procedures involved in selecting and setting up audits at investigator sites. 09:40 Workshop 1 - Planning the Effective Audit 10:30 Break 10:45 Source Data Verification The need for and purpose of verifying data. 11:25 Workshop 2 - Source Data Verification 12:30 Lunch 13:30 IMP Management The requirements surrounding the distribution of investigational medicinal products. Accountability from release to destruction. 14:15 Critical Document Audits The conduct of other study specific audits including protocols, databases and reports. 15:00 Break 15:15 Non-compliance Determining the acceptability of data. 16:00 Fraud - Fact or Fiction? How to identify fraud and its consequences 16:45 End of Day Questions and Answers 17:00 Close of Day Day 3 08:50 Questions and Answers from Days 1 and 2 09:00 Auditing Third Parties A review of audits of contract research organisations. 10:00 System Audits The concept of auditing processes across many clinical trials, including a practical exercise in process mapping. 10:45 Break 11:00 Workshop 3 - Process Mapping 11:45 Effective Audits Where theory meets reality. 12:30 Lunch 13:20 Audit Reports - Closing the Loop An examination of the processes which follow the evidence gathering phase of the audit. 14:20 Workshop 4 - Audit Reports Audit reports, corrective and preventive action. 15:00 Break 15:10 Regulatory Inspection Auditors and regulatory inspections -how the QA team can help the organisation to perform during a regulatory inspection. 15:55 Final Questions and Answers 16:10 Close of Course Extra Information Face-to-face course Course Material Course material will be available in PDF format for delegates attending this course. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course. The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions. Remote course Course Material This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. Please note this course will run in UK timezone. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course Access to an online course group to enhance networking. You will need a stable internet connection, a microphone and a webcam. CPD Points 17 Points Development Level Develop

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Portfolio Management for Stakeholders: In-House Training This course equips and enables project, program, and functional managers (line managers) to support and contribute to starting, restarting or sustaining the implementation and effectiveness of portfolio management in an organization. Emphasis is on improving collaboration and planning between functional business areas and project/program organizations responsible for delivering investments in business change through successful delivery of projects and programs. Good functional, project, and program managers become 'great' when they understand, advocate, and effectively contribute to achieving 'real' business value through portfolio management. What you Will Learn At the end of this program, you will be able to: Outline the benefits of portfolio management State the importance of linking the strategic objectives to the initiatives in the organization Chart the portfolio governance structure Assist in the inventory of ongoing and new initiatives Identify portfolio and sub-portfolio categories Support the PMO in the prioritization of initiatives using Multi-criteria Analysis and other selection tools Collaborate with the PMO in balancing the portfolio based on the optimal use of resources and priorities Participate in resource forecasting and planning Demonstrate thresholds and variance reporting criteria Describe the purpose of Stage Gate Funding Report status against a portfolio delivery plan Present your initiative in Stage Gate Reviews List the benefits that are being realized by the initiative Foundation Concepts Portfolio Life Cycles Portfolio Governance Prioritizing Initiatives Prioritize Foundation Multi-Criteria Analysis Analytical Hierarchy Process (AHP) Strategic Alignment Balancing the Portfolio Resources, Budgets, and Equipment Communicating Decisions Planning the Portfolio Planning Review Cycles Using Stage Gate Funding Setting Thresholds and Variance Reporting Tool Examples Portfolio Delivery 'Cycle' Project and Program Life Cycles Stage Gate Reviews Interaction with the Portfolio Delivery Board Project, Program, and Functional Managers Roles and Responsibilities

Disciplined Agile Scrum Master (DASM): Virtual In-House Training Is your team treading water using waterfall? Do you feel trapped in an agile framework? Would you like to find solutions to the problems you've been wrestling with? Are you looking for ways to enhance your team's agility? Break free from your old ways by choosing a way of working that fits your team's context. Find strategies to improve your processes and strengthen your team with the Disciplined Agile® tool kit. Disciplined Agile Scrum Master is a nine-lesson, instructor-led course that shows you how to use Disciplined Agile (DA™) to improve your team's way of working. In just two days, you will become familiar with foundational agile and lean practices that DA supports, practice using the tool kit to solve problems, and learn how to build high-performance teams. Filled with activities, animations, supplemental reading, and more, this course will prepare you to take the Disciplined Agile Scrum Master (DASM) exam and, equally important, start using Disciplined Agile immediately. #BBD0E0 » What You Will Learn After the completion of this course, you will be able to: Apply foundational agile and lean practices in your own team setting Describe what business agility is and how it is core to value proposition of Disciplined Agile® Describe the significance of the Disciplined Agile mindset Define the DA™ principles, promises, and guidelines and how they set Disciplined Agile apart from other frameworks Explain how people are organized into DA teams Define the primary DA roles and how they each are key to the success of a self-organizing agile team Explain how to help your team work well together using the Lean principle of 'respect people' Analyze your team's context to make better process-related decisions Select the best-fit DA life cycles for your teams Apply the five DA steps of choosing your team's way of working (WoW) Apply the relevant agile and lean techniques to successfully initiate your team Apply the relevant agile and lean techniques to support your team producing business value Apply the relevant agile and lean techniques to support your team releasing their work into production Apply the relevant agile and lean techniques to support your team on an ongoing basis Recognize when to be resilient List and define the principles of Lean Significance of the Disciplined Agile® Mindset Business agility and how it is core to value proposition of Disciplined Agile Eight DA principles and how they are core to what sets Disciplined Agile apart from other agile frameworks Which situations each of the DA™ life cycles is best applied DA Practice of choosing a team's way of working (WoW) Foundations of Agile How people are organized into DA teams Primary DA roles and how they each are key to the success of a self-organizing agile team Help your team work well together (Lean principle 'Respect people') Inception phase and why it is important DA tool kit to tailor your way of working within a select phase according to context Agile techniques and ceremonies relevant to Inception Construction phase and why it is important Agile techniques and ceremonies that take place during Construction Eliminate Waste and Build Quality (Lean principles) Deliver Value Quickly (Lean principle) Transition phase and why it is important Ongoing phase and why it is important Learn Pragmatically (Lean principle) Elements of the process blade (onion) diagram Principles of Lean When to be resilient Benefits of explicit workflow Kaizen loops and PDSA techniques for continuous improvement Options for cross-team learning: "community of practice" and "center of excellence"

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Disciplined Agile Senior Scrum Master (DASSM): Virtual In-House Training Do you want to take Disciplined Agile® to a new level? Are you looking for tools to solve complex problems and enhance your organization's agility? Do you want to learn how to lead your team to excellence? Expand your knowledge and build practical skills around Disciplined Agile®, business agility, leadership, and team development. Disciplined Agile Senior Scrum Master is a nine-lesson, instructor-led course that shows you how to use the Disciplined Agile tool kit to solve a variety of advanced problems, work with allies within your organization, and optimize how teams work. You will gain knowledge in planning, reporting and metrics, and coordinating activities, as well as how to meet challenges in these areas. And you'll develop the skills you need to foster emotional intelligence, resolve conflicts, and lead high-performance teams at any stage of development. Filled with activities, supplemental reading, and more, this course will prepare you to take the Disciplined Agile Senior Scrum Master (DASSM) exam and, equally important, start using Disciplined Agile immediately within your leadership role. What You Will Learn After the completion of this course, you will be able to: Accelerate your ability to lead high-profile initiatives that are critical to enterprise success Take a deep dive into the Disciplined Agile® tool kit to develop a comprehensive understanding of the hundreds of practices and strategies it contains and the trade-offs of applying them Apply the Disciplined Agile tool kit in hands-on exercises to guide your team in choosing and evolving your best way of working (WoW) in real-life situations Use the tool kit to solve complex challenges commonly encountered in development and operational teams, the value stream, and at the enterprise level Learn how to design and implement metrics that measure your improvements in areas where your teams are struggling Understand how to nurture emotional intelligence Feel confident empowering others on your team(s) Learn how to lead your teams in any situation to improve value delivery for your customers Apply the Disciplined Agile tool kit to guide your team in choosing and evolving the best way of working (WoW) in the situation you face Be prepared to take the Disciplined Agile® Senior Scrum Master (DASSM) exam and earn a valuable, credible certification Roles and responsibilities of DASSM Tuckman Team Development Model Emotional intelligence and why it is essential to team performance Business agility Tactical scaling factors in more complex situations Disciplined DevOps layer 'Test-first' method as it relates to the quality of requirements Scope and purpose of the value stream layer Coordinate activities process goal and why it is important Value creation structure of teams DA™ tool kit to optimize the flow of work and solve challenges related to coordinating and collaborating across teams, or within a larger team of teams Thomas-Kilmann Conflict Resolution Planning Five levels of scope Metrics

Agile Sprint Planning: In-House Training The goal of the course is to provide you and your team with the ability to develop effective and realistic Sprint plans. Without effective Sprint Plans, iterations are set up for failure. But Sprint Planning cannot be improved on its own, in isolation. The Scrum processes are highly intertwined and influence each other. The surrounding artifacts, events, and roles must be examined closely, and enhanced, in order to improve Sprint Planning. This course will remind you of the theory to reinforce the principles, but will concentrate on next-level skills, so that you and the team are able to create realistic and usable Sprint Plans. This course is not introductory. You are already aware of the Scrum framework and have been implementing Scrum on your projects. Now is the time to improve efficiency and effectiveness, to facilitate successful Agile projects. What you will Learn You'll learn how to: Identify and correlate the key symptoms and root causes of ineffective sprint plans Improve key Product Backlog elements Evaluate Agile roles in sprint planning Appraise key product practices Enhance project transparency The Product Backlog User stories Acceptance Criteria Backlog Refinement Supporting Roles Product Owner (the Backlog) Development Team Stakeholders and SMEs Supporting Product Practices Roadmaps and release plans and story maps Definition of Done Technical Debt Transparency Daily Scrums Information radiators Retrospectives Sprint Planning Capacity and Velocity Sprint Planning Meetings The Sprint Backlog Summary What did we learn, and how can we implement this in our work environments?

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